A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis
ConditionRheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbVie
About this trial
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA).
This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide.
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At any time prior to the Screening Visit, participant must have been treated for > or = 3 months with at least 1 b/tsDMARD therapy but continued to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. The maximum cap for prior use of b/tsDMARD is 2.
Participant must be on a stable dose of methotrexate (MTX)
Disqualifiers
Participant is taking nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, low-potency opioids (tramadol, codeine, hydrocodone, alone or in combination with acetaminophen), oral corticosteroids (equivalent to ≤ 10 mg/day of prednisone), or inhaled corticosteroids for stable medical conditions unless they have been on stable doses for ≥ 1 week prior to Baseline Visit.
History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than rheumatoid arthritis.
Trial design
Design model
Parallel
Treatments tested in this trial
Lutikizumab
DrugSubcutaneous (SC) injection
Placebo
DrugSubcutaneous (SC) injection
Ravagalimab
DrugSubcutaneous (SC) injection
Treatment groups
180 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Substudy 1: Lutikizumab MonotherapyExperimental treatment 1 intervention
Group B: Substudy 1: Matching Placebo MonotherapyPlacebo comparator 1 intervention
Group C: Substudy 2: Ravagalimab MonotherapyExperimental treatment 1 intervention
Group D: Substudy 2: Matching Placebo MonotherapyPlacebo comparator 1 intervention
Group E: SubStudy 3: Lutikizumab and Ravagalimab Combination TherapyExperimental treatment 2 interventions
Group F: Substudy 3: Matching Placebo Combination TherapyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)
Time frame
At Week 122
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame
Up to Approximately Week 22Secondary outcomes
1
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)
Time frame
At Week 122
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)
Time frame
At Week 123
Percentage Of Participants Achieving Low Disease Activity (LDA) per Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP)
The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity). LDA is defined as a score of \< or = to 3.2.
Time frame
At Week 124
Percentage Of Participants Achieving Clinical Remission (CR) per DAS28 (CRP)
The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity). CR remission is defined as a score of less than 2.6
Time frame
At Week 12 Source ClinicalTrials.gov